ADVM Adverum Biotechnologies Inc.

14.24
+0.22  (+2%)
Previous Close 14.02
Open 14.17
52 Week Low 7.36
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Market Cap $1,388,081,067
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Enterprise Value $911,193,385
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Av. Daily Volume 897,294
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Upcoming Catalysts

Drug Stage Catalyst Date
ADVM-022 - INFINITY
Diabetic macular edema
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Phase 1
Pivotal trial to commence mid-2021.
ADVM-043
Alpha-1 Antitrypsin (A1AT) Deficiency
Phase 1/2
Phase 1/2
Development to be discontinued - noted November 1, 2018.
AVA-101
Wet age-related macular degeneration (Wet-AMD)
Phase 2a
Phase 2a
Phase 2a negative data released June 2015 (met primary endpoint but increase in retinal thickness). As a result Phase 2b development will not proceed.

Latest News

  1. REDWOOD CITY, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the company's presentation at the Piper Sandler 32nd Annual Virtual Healthcare Conference.

    Adverum's video webcast will be accessible on demand beginning today at 10:00 am ET under Events and Presentations in the Investors section of the company's website. This webcast will be available on the Adverum website for 30 days.

    About Adverum Biotechnologies
    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the…

    REDWOOD CITY, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the company's presentation at the Piper Sandler 32nd Annual Virtual Healthcare Conference.

    Adverum's video webcast will be accessible on demand beginning today at 10:00 am ET under Events and Presentations in the Investors section of the company's website. This webcast will be available on the Adverum website for 30 days.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.





    Investor and Media Inquiries:
    Myesha Lacy
    Adverum Biotechnologies, Inc.
    
    1-650-649-1257

    Primary Logo

    View Full Article Hide Full Article
  2. -- Maintained efficacy and greatly reduced anti-VEGF treatment burden after a single IVT injection of ADVM-022 --

    -- Robust preliminary aqueous anti-VEGF protein expression observed at 18 months in Cohort 1

    -- Well tolerated with ocular cell grades and steroid eye drop use decreasing over time --

    -- First pivotal trial planned for mid-2021 following regulatory agency discussions --

    -- Company to host webcast with Key Opinion Leaders to discuss new OPTIC data today, Saturday, November 14, 2020 at 7:30 am PT / 10:30 am ET --

    REDWOOD CITY, Calif., Nov. 14, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced…

    -- Maintained efficacy and greatly reduced anti-VEGF treatment burden after a single IVT injection of ADVM-022 --

    -- Robust preliminary aqueous anti-VEGF protein expression observed at 18 months in Cohort 1

    -- Well tolerated with ocular cell grades and steroid eye drop use decreasing over time --

    -- First pivotal trial planned for mid-2021 following regulatory agency discussions --

    -- Company to host webcast with Key Opinion Leaders to discuss new OPTIC data today, Saturday, November 14, 2020 at 7:30 am PT / 10:30 am ET --

    REDWOOD CITY, Calif., Nov. 14, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced positive new interim data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration (AMD).

    "With these impressive OPTIC data and the removal of the partial clinical hold on ADVM-022 by the FDA, our goal is to continue to advance into pivotal trials to demonstrate the transformative potential of our gene therapy," said Laurent Fischer, M.D., chief executive officer of Adverum. "We are excited that ADVM-022 has the potential to be a "one and done" IVT injection that may dramatically reduce the treatment burden for the millions of patients with wet AMD and DME worldwide. Particularly during COVID-19, we are reminded of the benefits that ADVM-022, a novel gene therapy that has demonstrated long-term treatment benefit after one in-office IVT injection, could deliver to patients. Our Adverum team is laser-focused on accelerating the development and future commercial launch plans for ADVM-022. I am humbled by the dedication of the retina specialists and their staff, and our employees, to help progress our clinical trials which generate the data necessary to drive our mission of helping patients with severe ocular diseases."

    Adverum reported new interim data from the OPTIC trial (October 15, 2020 cutoff date) that further demonstrate the transformative potential of ADVM-022 to greatly reduce the anti-VEGF injection burden for patients with wet AMD:

    • ADVM-022 continues to maintain efficacy at both high and low doses (n=30)
      • Mean BCVA1 maintained
      • Mean CRT2 maintained to improved
    • Durability out to 92 weeks from a single IVT injection with zero supplemental injections in Cohort 1 (high dose)
    • Robust preliminary aqueous anti-VEGF protein expression observed at 18 months in Cohort 1 (high dose)
      • Mean aqueous anti-VEGF protein level 1840 ng/mL
    • Substantial reduction in annualized anti-VEGF injection frequency3 following ADVM-022 in patients who previously required frequent injections:
      • High dose: 99% reduction
      • Low dose: 85% reduction
    • Most patients are supplemental anti-VEGF injection free in OPTIC:
      • High dose: 14/154 patients injection free
      • Low dose: 10/155 patients injection free
    • ADVM-022 continues to be well tolerated with a favorable safety profile at both high and low doses
      • All ADVM-022-related ocular adverse events (AE) were mild (78%) to moderate (22%)
      • Ocular inflammation, when observed, has been responsive to steroid eye drops and overall is decreasing over time
      • No clinical or fluorescein evidence of posterior inflammation
        • No vasculitis, retinitis, choroiditis, vascular occlusions, or endophthalmitis

    OPTIC Phase 1 Clinical Trial Data:

    Results Following a Single ADVM-022 Dose:Cohort 1

    Cohort 2

    Cohort 3Cohort 4
    Patientsn=6n=6n=9n=9
    Median (Range) Follow-up Visit (Weeks) 86

    (64 to 92)
    64

    (64 to 68)
    48

    (32 to 48)
    16

    (12 to 24)
    ADVM-022 Dose

    High dose

    6 x 10^11 vg/eye
    Low dose

    2 x 10^11 vg/eye
    Low dose

    2 x 10^11 vg/eye
    High dose

    6 x 10^11 vg/eye
    Prophylactic Steroid Regimen

    13-day oral 13-day oral6-week eye drops6-week eye drops
    Supplemental Anti-VEGF Injection Use: 
    Number of patients supplemental injection free6/6 patients3/6 patients7/9 patients8/9 patients
    Total supplemental anti-VEGF injections0 injections17 injections in 3 patients8 injections in 2 patients1 injection in 1 patient
    Follow-up BCVA1 and CRT2:  
     All PatientsAll PatientsSupp.

    IVT-free

    Patients

    50% (3/6)
    All Patients



    Supp.

    IVT-free

    Patients

    78% (7/9)
    N/A
    BCVA mean change from baseline (letters)-2.5+0.2+1.0-0.9+4.1N/A
    CRT mean change from baseline (μm)-19.7 μm-1.0 μm-23.7 μm-113.4 μm-132.7 μmN/A
    Ocular Inflammation and Management: 
    % patients with any cellular inflammation at most recent visit33%0%11%22%
    Average # of daily steroid eye drops61.20.50.81.9

    1 Best corrected visual acuity (BCVA)

    2 Central retinal thickness (CRT)

    3 Annualized rate (Before) = (number of IVTs in 12 months prior to ADVM-022) / (days from the first IVT in the past 12 months to ADVM-022 / 365.25)

    Annualized rate (After) = (number of aflibercept IVTs since ADVM-022) / (days from ADVM-022 to the last study follow-up / 365.25)

    4 All patients from Cohort 1 (n=6) and Cohort 4 (n=9)

    5 All patients from Cohort 2 (n=6) and Cohort 3 (n=9)

    6 Average calculated across entire cohort at their last follow up visit

    Carl D. Regillo, M.D., F.A.C.S, director of the Wills Eye Hospital Retina Service said, "The sustained anatomical response observed in OPTIC in my experience is unprecedented, extending out beyond 18 months following a single intravitreal injection of ADVM-022. In addition, ADVM-022 has been well tolerated, and ocular inflammation, when observed, is responsive to steroid eye drops and decreases over time. ADVM-022 is a novel gene therapy that has demonstrated the potential to transform the treatment of patients living with wet AMD."

    Aaron Osborne, MBBS, chief medical officer of Adverum, added, "In OPTIC, we have enrolled the wet AMD patients requiring frequent injections to manage their condition, so we are very pleased with the significant reduction in anti-VEGF treatment burden demonstrated in both the high and low dose of ADVM-022. Additionally, the robust ocular anti-VEGF levels are a clear indication of ADVM-022's stable, continuous therapeutic protein expression out to 18 months. We will continue to monitor our 30 patients and plan to present longer-term data, including additional anti-VEGF protein expression data from patients who consent to aqueous taps, in the first half of 2021. We are planning for our end-of-Phase 1 meeting with the U.S. FDA on our development program, including the initiation of our first pivotal clinical trial in wet AMD in mid-2021. With these continued impressive data, we believe that both doses warrant further investigation."

    Future Plans

    ADVM-022 in wet AMD

    • Present longer-term data from OPTIC Phase 1 trial, including additional anti-VEGF protein expression data, in the first half of 2021
    • Initiate a pivotal trial mid-2021

    ADVM-022 in DME

    • Present clinical data from INFINITY Phase 2 trial in the second half of 2021

    Adverum Webcast:

    Date: November 14, 2020

    Time: 7:30 – 9:00 am PT (10:30 am – 12:00 pm ET)

    Presenters:

    • Carl D. Regillo, M.D., F.A.C.S, director of the Wills Eye Hospital Retina Service and investigator in the OPTIC Phase 1 trial
    • Steven Yeh, M.D., associate professor, director, section of uveitis and ocular immunology, Emory Eye Center
    • David S. Boyer, M.D., senior partner, Retina-Vitreous Associates Medical Group and adjunct clinical professor of ophthalmology, University of Southern California/ Keck School of Medicine, Los Angeles, investigator in the OPTIC Phase 1 trial

    The live video webcast will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and refer to the "Adverum Biotechnologies' OPTIC Clinical Data Discussion Conference Call." It is recommended call participants dial in 15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    About the OPTIC Phase 1 Trial of ADVM-022 in Wet AMD

    This multi-center, open-label, Phase 1, dose-ranging trial is designed to assess the safety and tolerability of a single intravitreal (IVT) administration of ADVM-022 in patients with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment. Patients received high dose (6 x 10^11 vg/eye) of ADVM-022 in Cohort 1 (n=6) and Cohort 4 (n=9) and patients received low dose (2 x 10^11 vg/eye) of ADVM-022 in Cohort 2 (n=6) and Cohort 3 (n=9). Patients in Cohorts 3 and 4 received six weeks of prophylactic steroid eye drops rather than 13 days of prophylactic oral steroids which were used in Cohorts 1 and 2. The primary endpoint of the trial is the safety and tolerability of ADVM-022 after a single IVT administration. Secondary endpoints include changes in best-corrected visual acuity (BCVA), measurement of central retinal thickness (CRT), as well as the need for supplemental anti-VEGF injections. Each patient enrolled will be followed for a total of two years.

    Eleven leading retinal centers across the United States are participating in the OPTIC Phase 1 trial for ADVM-022. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03748784.

    About ADVM-022 Gene Therapy

    ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal injection (IVT), designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

    In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for ADVM-022 for the treatment of wet AMD.

    Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME.

    About Wet AMD

    Age-related macular degeneration (AMD) is a progressive disease affecting the macula, the region of the retina at the back of the eye responsible for central vision. In patients with wet AMD, an aggressive form of AMD, abnormal blood vessels grow underneath and into the retina. These abnormal blood vessels leak fluid and blood into and beneath the retina, causing vision loss.

    Wet AMD is a leading cause of vision loss in patients over 60 years of age, with a prevalence of approximately 1.2 million individuals in the U.S. and 3 million worldwide1. The incidence of new cases of wet AMD in the U.S. is approximately 150,000 to 200,000 annually, and this number is expected to grow significantly as the country's population ages2,3.

    The current standard-of-care therapies for wet AMD are anti-VEGF proteins. These therapies can be burdensome, as patients generally require chronic intravitreal (IVT) injection of anti-VEGF protein every 4-12 weeks. Compliance with this regimen can be difficult for patients and their caregivers, leading to compliance deficiencies and loss of vision from underdosing. It is estimated that these standard-of-care branded anti-VEGF therapies used for the treatment of wet AMD, DR, retinal vein occlusion, and other ocular diseases generated in excess of $11 billion in sales worldwide in 20194.

    1 Arch Ophthalmol. 2004;122(4):564-572. doi:10.1001/archopht.122.4.564.

    2 Brown GC, Brown MM, Sharma S, et al. The Burden of Age-Related Macular Degeneration: A Value-Based Medicine Analysis. Transactions of the American Ophthalmological Society. 2005.

    3 California Retina Consultants. Advances in Wet AMD. Available at: https://www.californiaretina.com/advances-in-wet-amd/

    4 Year-end 2019 financial statements from Regeneron, Roche, and Novartis.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; the expected growth of the incidence of new cases of wet AMD in the U.S. as its population ages; Adverum's expectations that it will present longer-term data from the OPTIC Phase 1 trial for ADVM-022 in wet AMD in the first half of 2021 and data from the INFINITY Phase 2 trial for ADVM-022 in DME in the second half of 2021; Adverum's plans to accelerate the development and future commercial launch plans for ADVM-022; and Adverum's expectations as to its plans to advance ADVM-022 in wet AMD by initiating a pivotal trial mid-2021. All of these statements are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not achieve any of these in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for preliminary or interim results of clinical trials to change as the clinical trial continues or in connection with the preparation and analysis of final results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on November 5, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor and Media Inquiries:
    Myesha Lacy
    Adverum Biotechnologies, Inc.
    
    1-650-649-1257

    Primary Logo

    View Full Article Hide Full Article
  3. -- Company to host conference call and webcast with KOLs to discuss new data from Cohorts 1-4 of OPTIC Phase 1 trial of ADVM-022 for wet AMD on November 14, 2020 at 7:30 am PT --

    -- FDA removes partial clinical hold on ADVM-022 --

    -- Planning to start a pivotal trial for ADVM-022 in wet AMD mid-2021 --

    -- INFINITY Phase 2 trial for ADVM-022 enrolling patients with DME;
    Data expected 2H21 --

    REDWOOD CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported recent business progress and financial results for the third quarter ended September 30, 2020.

    "We are continuing execution and progress…

    -- Company to host conference call and webcast with KOLs to discuss new data from Cohorts 1-4 of OPTIC Phase 1 trial of ADVM-022 for wet AMD on November 14, 2020 at 7:30 am PT --

    -- FDA removes partial clinical hold on ADVM-022 --

    -- Planning to start a pivotal trial for ADVM-022 in wet AMD mid-2021 --

    -- INFINITY Phase 2 trial for ADVM-022 enrolling patients with DME;

    Data expected 2H21 --

    REDWOOD CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported recent business progress and financial results for the third quarter ended September 30, 2020.

    "We are continuing execution and progress across our organization as preparations are underway for us to become a late-stage gene therapy company next year with two programs underway for ADVM-022, in wet AMD and DME," said Laurent Fischer, M.D., chief executive officer of Adverum. "We believe that ADVM-022 has the potential to reduce the treatment burden for the millions of patients living worldwide with these chronic ocular diseases with a potential "one and done" treatment. The FDA's recent removal of the partial clinical hold is an important milestone achievement as we intend to initiate our pivotal trial for ADVM-022 in wet AMD in mid-2021. Based on the positive data from OPTIC in wet AMD and the progress with INFINITY in DME, we are preparing to meet with regulators to discuss our development plans for ADVM-022 in order to accelerate our development, manufacturing, and future commercial launch plans for this therapy. We continue to expand our team of leaders as we establish world-class capabilities across operational functions to plan for future opportunities to deliver novel gene therapies to patients."

    Recent Progress

    • Adverum has received notification that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on ADVM-022 after the company provided the agency with the requested information related to CMC. The partial hold did not affect the INFINITY Phase 2 trial for DME or current doses evaluated in the OPTIC Phase 1 trial for wet AMD. Adverum plans to meet with the agency to discuss the company's plans for pivotal trials to support the filing of a Biologics License Application (BLA) for ADVM-022 in wet AMD.
    • Adverum raised approximately $203.4 million in net proceeds from an underwritten public offering in August 2020.
    • Thomas Kochy joined Adverum as vice president, commercial and program strategy. Mr. Kochy has program leadership, product marketing, and sales management expertise, including 10 years of experience in Genentech's Ophthalmology franchise.
    • Christopher J. Morrison, Ph.D. joined Adverum as vice president, process science. Dr. Morrison has 10 years of pharmaceutical industry experience and has a background in gene therapy, recombinant adeno-associated viral vector (rAAV) process development, and clinical manufacturing.

    Future Plans

    ADVM-022 in wet AMD

    • Present new clinical data from Cohorts 1-4 of OPTIC Phase 1 trial during KOL call and webcast on November 14, 2020
    • Initiate a pivotal trial mid-2021

    ADVM-022 in DME

    • Present clinical data from INFINITY Phase 2 trial in the second half of 2021

    Manufacturing

    • Initiating process scale-up from 200L to 1000L scale to support the potential future commercial product launch of ADVM-022
    • Beginning to plan for in-house GMP capabilities with initiation of site selection

    Adverum Webcast with Key Opinion Leaders:

    On Saturday, November 14, the Company will host a webcast with Key Opinion Leaders to review new OPTIC data in lieu of a quarterly conference call this quarter.

    Date: November 14, 2020

    Time: 7:30 – 9:00 am PT (10:30 am – 12:00 pm ET)

    Presenters:

    • Carl Regillo, M.D., F.A.C.S, chief of retina services at Wills Eye Hospital and investigator in the OPTIC Phase 1 trial
    • Steven Yeh, M.D., associate professor, director, section of uveitis and ocular immunology, Emory Eye Center
    • David S. Boyer, M.D., senior partner, Retina-Vitreous Associates Medical Group and adjunct clinical professor of ophthalmology, University of Southern California/ Keck School of Medicine, Los Angeles, investigator in the OPTIC Phase 1 trial

    The live video webcast will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and refer to the "Adverum Biotechnologies' OPTIC Clinical Data Discussion Conference Call." It is recommended call participants dial in 15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    Presentation of Existing OPTIC Data:                                    

    Event: Retina Subspecialty Day 2020 Virtual Meeting

    Title: Intravitreal Gene Therapy with ADVM-022 for Neovascular AMD: OPTIC Phase 1 Study

    Date: November 13, 2020

    Time: 2:15 pm PT

    Presenter: Carl Regillo, M.D., F.A.C.S, chief of retina services at Wills Eye Hospital

    Presentation: At the beginning of Dr. Regillo's presentation, Adverum plans to post the presentation under Events and Presentations in the Investors section of the company's website.

    Presentation of Existing OPTIC Data:

    Event: AAO 2020 Virtual Meeting

    Title: Phase 1 Study of Intravitreal Gene Therapy with ADVM-022 for Neovascular AMD (OPTIC Trial Cohorts 1-4, from the August 10, 2020 data presentation)

    Date: November 14-17, 2020

    Presenter: Arshad M. Khanani, M.D., M.A., managing partner and director of clinical research, Sierra Eye Associates, clinical associate professor of ophthalmology, University of Nevada

    Presentation: On or before November 13, 2020 the virtual presentations will be available on demand to AAO participants, and Adverum plans to post the presentation under Events and Presentations in the Investors section of the company's website.

    COVID-19

    To date, Adverum has experienced limited impact from COVID-19 on its operations and ongoing clinical programs, including the OPTIC and INFINITY clinical trials. The company is continuing to monitor and attempt to address or limit the potential impacts of COVID-19 on its employees and operations, patient safety, patient enrollment, continued participation of patients already enrolled in the company's clinical studies, protocol compliance, data quality, and overall study integrity.

    Financial Results for the Three Months Ended September 30, 2020

    • Cash, cash equivalents and short-term investments were $454.5 million as of September 30, 2020, including approximately $203.4 in net proceeds from an underwritten public offering in August 2020, compared to $166.0 million as of December 31, 2019. Adverum expects this quarter-end cash position to fund operations into mid-2022.
    • Research and development expenses were $16.7 million for the three months ended September 30, 2020, compared to $9.9 million for the same period in 2019. Research and development expenses increased primarily due to higher personnel-associated costs, material production costs, and laboratory expenses. Stock-based compensation expense included in research and development expenses was $2.1 million for the third quarter of 2020.
    • General and administrative expenses were $11.4 million for the three months ended September 30, 2020, compared to $7.4 million for the same period in 2019. General and administrative expenses increased primarily due to higher personnel-associated costs as well as depreciation expense for Adverum's new headquarters. Stock-based compensation expense included in general and administrative expenses was $4.0 million for the third quarter of 2020.
    • Net loss was $27.8 million, or $0.31 per basic and diluted share, for the three months ended September 30, 2020, compared to $16.1 million, or $0.25 per basic and diluted share, for the same period in 2019.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; Adverum's expectations that it will present additional data from all four cohorts of the OPTIC Phase 1 trial for ADVM-022 in wet AMD in November 2020; Adverum's expectations as to its plans to advance ADVM-022 in wet AMD by initiating a pivotal trial mid-2021 and in DME by continuing to enroll patients in the INFINITY trial, Adverum's expectations that it will present data from the INFINITY trial in the second half of 2021; Adverum's expectations that it will accelerate its development, manufacturing, and commercial launch plans for ADVM-022; and Adverum's expectations that its current cash position will fund its operations into mid-2022. All of these statements are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not achieve any of these in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for preliminary or interim results of clinical trials to change as the clinical trial continues or in connection with the preparation and analysis of final results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on November 5, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor and Media Inquiries:

    Myesha Lacy

    Adverum Biotechnologies, Inc.



    1-650-649-1257

     
    Adverum Biotechnologies, Inc.
    Consolidated Balance Sheets
    (In thousands)
         
      September 30

      December 31,
       2020   2019 
      (Unaudited)  (1) 
    Assets     
    Current assets:    
    Cash and cash equivalents $72,696  $65,897 
    Short-term investments  381,766   100,138 
    Prepaid expenses and other current assets  5,238   9,835 
    Total current assets  459,700   175,870 
    Operating lease right-of-use asset  19,698   20,963 
    Property and equipment, net  27,295   24,884 
    Restricted cash  999   999 
    Deposit and other long-term assets  19   11 
    Total assets $507,711  $222,727 
         
    Liabilities and stockholders' equity     
    Current liabilities:    
    Accounts payable $3,034  $4,103 
    Accrued expenses and other current liabilities  8,642   11,271 
    Lease liability, current portion  4,435   4,034 
    Total current liabilities  16,111   19,408 
    Lease liability, net of current portion  26,752   28,214 
    Other noncurrent liabilities  136   148 
    Total liabilities  42,999   47,770 
    Stockholders' equity:    
    Common stock  10   7 
    Additional paid-in capital  930,211   560,704 
    Accumulated other comprehensive loss (605)  (725)
    Accumulated deficit  (464,904)  (385,029)
    Total stockholders' equity  464,712   174,957 
    Total liabilities and stockholders' equity $507,711  $222,727 
         
    (1) Derived from Adverum's annual audited consolidated financial statements.
         

     

     
    Adverum Biotechnologies, Inc.
    Consolidated Statements of Operations
    (In thousands except per share data)
    (Unaudited)
             
      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
       2020   2019   2020   2019 
             
    Collaboration and license revenue $-  $250  $-  $250 
             
    Operating expenses:        
    Research and development  16,653   9,944   50,581   29,045 
    General and administrative  11,351   7,389   30,989   20,097 
    Total operating expenses  28,004   17,333   81,570   49,142 
    Operating loss  (28,004)  (17,083)  (81,570)  (48,892)
    Other income, net  235   965   1,695   3,331 
    Net loss  (27,769)  (16,118)  (79,875)  (45,561)
    Net loss per share — basic and diluted $(0.31) $(0.25) $(0.99) $(0.71)
    Weighted-average common shares outstanding - basic and diluted  88,867   64,484   80,995   63,764 
             

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  4. -- Dr. Carl Regillo to present OPTIC data at the Retina Subspecialty Day on Friday, November 13, 2020 at 2:15 pm PT --

    -- Company to host webcast with key opinion leaders on Saturday, November 14, 2020 at 7:30 am PT --

    REDWOOD CITY, Calif., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the presentation of additional clinical data for Cohorts 1-4 in the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in wet age-related macular degeneration (wet AMD). This will be in the form of a live broadcast during the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting.

    -- Dr. Carl Regillo to present OPTIC data at the Retina Subspecialty Day on Friday, November 13, 2020 at 2:15 pm PT --

    -- Company to host webcast with key opinion leaders on Saturday, November 14, 2020 at 7:30 am PT --

    REDWOOD CITY, Calif., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the presentation of additional clinical data for Cohorts 1-4 in the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in wet age-related macular degeneration (wet AMD). This will be in the form of a live broadcast during the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting.

    Presentation of New OPTIC Data:

    Event: Retina Subspecialty Day 2020 Virtual Meeting

    Title: Intravitreal Gene Therapy with ADVM-022 for Neovascular AMD: OPTIC Phase 1 Study

    Date: November 13, 2020

    Time: 2:15 pm PT

    Presenter: Carl Regillo, M.D., F.A.C.S, chief of retina services at Wills Eye Hospital

    Presentation: At the beginning of Dr. Regillo's presentation, Adverum plans to issue a press release and post the new data presentation under Events and Presentations in the Investors section of the company's website.

    Presentation of Existing OPTIC Data:

    Event: AAO 2020 Virtual Meeting

    Title: Phase 1 Study of Intravitreal Gene Therapy with ADVM-022 for Neovascular AMD (OPTIC Trial Cohorts 1-4, from the August 10, 2020 data presentation)

    Date: November 14-17, 2020

    Presenter: Arshad M. Khanani, M.D., M.A., managing partner and director of clinical research, Sierra Eye Associates, clinical associate professor of ophthalmology, University of Nevada

    Presentation: On or before November 13, 2020 the virtual presentations will be available on demand to AAO participants, and Adverum plans to post the presentation under Events and Presentations in the Investors section of the company's website.

    Adverum Webcast:

    Date: November 14, 2020

    Time: 7:30 – 9:00 am PT (10:30 am – 12:00 pm ET)

    Presenters:

    • Carl Regillo, M.D., F.A.C.S, chief of retina services at Wills Eye Hospital and investigator in the OPTIC Phase 1 trial
    • Steven Yeh, M.D., associate professor, director, section of uveitis and ocular immunology, Emory Eye Center
    • David S. Boyer, M.D., senior partner, Retina-Vitreous Associates Medical Group and adjunct clinical professor of ophthalmology, University of Southern California/ Keck School of Medicine, Los Angeles, investigator in the OPTIC Phase 1 trial

    The live video webcast will be accessible under Events and Presentations in the Investors section of the company's website. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    On November 5, 2020 after market, Adverum plans to report recent business progress and financial results for the third quarter of 2020. The Company plans to host the KOL webcast on November 14, 2020 to review new OPTIC data instead of hosting a quarterly conference call this quarter.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Investor and Media Inquiries:
    Myesha Lacy
    Vice President, Investor Relations and Corporate Communications
    Adverum Biotechnologies, Inc.
    
    1-650-649-1257

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  5. REDWOOD CITY, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Christopher J. Morrison, Ph.D. joined the company as vice president, process development, reporting into Adverum's chief technology officer Angela Thedinga.

    "Chris brings a wealth of AAV gene therapy experience and will lead the scale-up of our commercial manufacturing process for ADVM-022," said Angela Thedinga, chief technology officer of Adverum. "We are delighted to welcome Chris at this exciting and pivotal time as we continue to execute on our strategy to deliver ADVM-022 to patients."

    Christopher J. Morrison, Ph.D…

    REDWOOD CITY, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Christopher J. Morrison, Ph.D. joined the company as vice president, process development, reporting into Adverum's chief technology officer Angela Thedinga.

    "Chris brings a wealth of AAV gene therapy experience and will lead the scale-up of our commercial manufacturing process for ADVM-022," said Angela Thedinga, chief technology officer of Adverum. "We are delighted to welcome Chris at this exciting and pivotal time as we continue to execute on our strategy to deliver ADVM-022 to patients."

    Christopher J. Morrison, Ph.D. has 10 years of pharmaceutical industry experience and has a background in gene therapy, recombinant adeno-associated viral vector (rAAV) process development, and clinical manufacturing. Most recently, he worked with ApicBio Therapeutics as senior director, biopharmaceutical development. Previously, he worked with Gemini Therapeutics as senior director, CMC operations. Earlier, he worked with Voyager Therapeutics, serving as director, biopharmaceutical development, promoted from associate director, head of process development. At Voyager, he directed the development and implementation of Phase 1/2 and Phase 3 manufacturing processes for multiple rAAV products of assorted serotypes and genomic construct produced by Sf9-Baculovirus or HEK293 transient transfection-based production systems. Dr. Morrison began his industry career at Pfizer as a senior scientist before being promoted to principal scientist, responsible for downstream purification processes for a broad range of biological molecules.

    Dr. Morrison earned a Doctorate of Philosophy in Chemical and Biological Engineering from Rensselaer Polytechnic Institute and a Bachelor of Science in Chemical Engineering from the University of Wisconsin at Madison.

    On September 14, 2020, the company granted Dr. Morrison a stock option to purchase 100,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to his entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to his continued service with Adverum.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: Adverum's advancements of current clinical trials, and its plans for later-stage clinical trials and growth and expansion of its process development capabilities; and Adverum's expectations as to the benefits it expects from the addition of Dr. Morrison. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on August 10, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor and Media Inquiries:
    
    Investors:
    Myesha Lacy
    Adverum Biotechnologies, Inc.
    
    1-650-649-1257
    
    Media:
    Cherilyn Cecchini, M.D.
    LifeSci Communications
    
    1-646-876-5196

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